11/12/2025

speaker
Brian

submissions, we resumed biopsy collection in November 2025. We now anticipate patient treatment starting in the fourth quarter of 2025. I will now hand the call over to Chief Commercial Officer Madhav Vasadavanthavada to discuss our commercial launch progress. Madhav?

speaker
Madhav Vasadavanthavada
Chief Commercial Officer

Thanks, Brian. Hello, everyone. Our launch momentum continues to accelerate on multiple fronts. patient demand continues to build, our relationships and trust with qualified treatment centers have grown stronger, and patient access to ZivaSkin across all payer types has continued to broaden. On our second quarter call, we mentioned more than a dozen initial patients were identified at the first two qualified treatment centers. Of these patients, We have already received ZivaSkin product order forms, or ZPOFs, for 12 patients. A ZPOF is an informed consent generated by the QTC physician after the patient has been consulted, a treatment decision has been made, and the patient and their families have decided to move forward. Insurance prior authorizations have been obtained for several patients already, and we expect these patients to be biopsied over the coming months as and when full financial clearance is in place. We are happy to also report that demand for ZivaSkin continues to grow. The number of identified eligible patients at our QTCs who are motivated to initiate the treatment process has now more than doubled to approximately 30 patients up from the 12-plus mentioned on the second quarter call. At the same time, the broader pool of potential ZivaSkin candidates at non-QTC referral sites continues to increase as our field force and promotional activities generate more ZivaSkin awareness in the marketplace, and many of these referral sites have initiated patient referrals to the qualified treatment centers, which is exactly what we were hoping for. Regarding QTC activations, we are delighted that Children's Hospital Colorado is our newest ZivaSkin qualified treatment center. Children's Hospital Colorado has an expert multidisciplinary team with years of EB experience And their commitment to onboarding ZivaSkin speaks to their belief in the benefits this therapy can bring to our dead patients. Activation of Children's Colorado brings the number of ZivaSkin qualified treatment centers to three alongside Lurie Children's Hospital of Chicago and Lucille Packard Children's Hospital in Stanford. We are also in active discussions with several EV centers across the US to strategically expand geographic footprint of ZivaSkin even further. These centers are advancing through the various stages of site onboarding and will continue to announce new centers as they are activated. Finally, regarding market access, we have seen a steady cadence of positive coverage decisions from both national and regional commercial health plans in the six months since approval. Importantly, policies covering Ziva Skin have been published by all major commercial payers, including United Healthcare, Cigna, Aetna, Anthem, and the majority of Blue Cross Blue Shield plans, all collectively covering more than 80% of all commercially insured lives. Now on the government payer front for Medicaid, we are happy to report that ZivaSkin now has received baseline coverage across all 51 state Medicaid programs in Puerto Rico effective October 1, 2025. Moreover, multiple state Medicaid programs have already published policies covering ZivaSkin signaling that payers recognize the value ZivaSkin brings to their patients and the healthcare system. As another major highlight, CMS has established a permanent product J-code for ZivaSkin that will go into effect on January 1, 2026. We believe that this product code will simplify claims and reimbursement processing between our QTCs and all payer types and will further support hospital adoption for ZivaSkin. In summary, we are very encouraged by the growing patient demand patients actively progressing toward treatment, continued growth of the QTC site network, and a favorable market access landscape for ZivaSkin. And we are looking forward to a strong start in 2026.

speaker
Manav
Investor Relations

With that, I'll now pass the call over to our Chief Financial Officer, Joe Vizzano, to discuss our financial results. Joe? Thanks, Manav.

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